Société : EORTC Lieu : Bruxelles Brussels Site source : Talent BE
The ClinicalDataManager will carry out the following tasks, with the close coaching of a ClinicalData Expert:
Clinical trial protocolDevelopment of the Data Management sections of the clinical trial protocolAssisting in the final review of the clinical trial protocol for consistency and operational feasibilityCase Report FormsDevelopment and definition of the study-specific Case Report Forms following the protocol and the EORTC Global LibraryDevelopment of the guidelines for Case Report Forms CompletionDatabase Design and ValidationDefinition of the requirements for database design by the Study DesignerDefining the visit scheduleDevelopment of the test plan and user tests for database validationCoordination of user tests regarding database validationCan perform the activities of a Study Designer as neededData handlingCoordination and control of data collection, data cleaning and data reporting activitiesApplication of QC to each stage in the data handling to ensure the data are reliable and processed in compliance with ICH-GCP requirements.Communication with the participating investigators to resolve queries and collect missing dataPerforming the reconciliation of SAEs with the clinicaldatabase when applicableOtherDevelopment and maintenance of the data management planPreparation and attendance of the medical review meetings with the Medical RepresentativeContribution to EORTC Group Members newslettersProper filing of all study-related documents, in compliance with ICH-GCP requirementsProfessional bachelor’s or master’s degree in a health-related or scientific disciplineComputer literate:
programming skills as well as skills in the use and management of computer databases are strong assetsKnowledge of CDISC standards preferred, SDTM in particularExperience in data monitoring and/or reviewing is an assetGood organisational & administrative skillsRigorous, attached to detailsExcellent analytical skillsTeam spiritEnglish very good (written & spoken), French & Dutch are assets Permanent contract Wage according to our Non-Profit organisation status Hybrid working environment (from Belgium) 30 days holidays (full time) Meal vouchers Pension plan Hospitalisation insurance and ambulatory care Homeworking allowance Reimbursement of public transport Free parking EORTC BruxellesBrussels
